Source: OJ L 2024/2847, 20.11.2024
ENRecital 55 Justification of non-applicability of requirements
Where certain essential cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirements are not applicable to a product with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately;, the manufacturer means a natural or legal person who develops or manufactures products with digital elements or has products with digital elements designed, developed or manufactured, and markets them under its name or trademark, whether for payment, monetisation or free of charge; should include a clear justification in the cybersecurity risk means the potential for loss or disruption caused by an incident and is to be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of the incident; assessment included in the technical documentation. This could be the case where an essential cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirement is incompatible with the nature of a product with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately;. For example, the intended purpose means the use for which a product with digital elements is intended by the manufacturer, including the specific context and conditions of use, as specified in the information supplied by the manufacturer in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation; of a product with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately; may require the manufacturer means a natural or legal person who develops or manufactures products with digital elements or has products with digital elements designed, developed or manufactured, and markets them under its name or trademark, whether for payment, monetisation or free of charge; to follow widely recognised interoperability standards means a standard as defined in Article 2, point (1), of Regulation (EU) No 1025/2012 of the European Parliament and of the Council (^29^); Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). even if its security features are no longer considered to be state of the art. Similarly, other Union law requires manufacturers means a natural or legal person who develops or manufactures products with digital elements or has products with digital elements designed, developed or manufactured, and markets them under its name or trademark, whether for payment, monetisation or free of charge; to apply specific interoperability requirements. Where an essential cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirement is not applicable to a product with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately;, but the manufacturer means a natural or legal person who develops or manufactures products with digital elements or has products with digital elements designed, developed or manufactured, and markets them under its name or trademark, whether for payment, monetisation or free of charge; has identified cybersecurity risks means the potential for loss or disruption caused by an incident and is to be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of the incident; in relation to that essential cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirement, it should take measures to address those risks means the potential for loss or disruption caused by an incident and is to be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of the incident; by other means, for instance by limiting the intended purpose means the use for which a product with digital elements is intended by the manufacturer, including the specific context and conditions of use, as specified in the information supplied by the manufacturer in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation; of the product to trusted environments or by informing the users about those risks means the potential for loss or disruption caused by an incident and is to be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of the incident;.